Adenosine Testing to DEtermine the Need for Pacing Therapy

Syncope Clinical Trial

— ADEPT-ILR  

Official title:

Adenosine Testing to DEtermine the Need for Pacing Therapy With the Additional Use of an Implantable Loop Recorder (ADEPT-ILR Study). The Efficacy of Permanent Pacing in Patients With Syncope and a Positive Intravenous Adenosine Test: a Randomised, Double-blind, Placebo-controlled, Cross-over Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01481168
• Other study ID #: 5883
• Secondary ID: FS/11/13/28690
• Status: Completed
• Phase: N/A
• First received: November 22, 2011
• Last updated: November 17, 2017
• Start date: April 12, 2012
• Est. completion date: January 26, 2017

Study information

• Verified date: November 2017
• Source: Newcastle-upon-Tyne Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether or not the intravenous adenosine test readily identifies patients with unexplained syncope who would benefit from permanent pacemaker implantation.

Description:

The investigation of syncope (transient loss of consciousness with loss of postural tone, collapse and spontaneous recovery) varies widely, is often lengthy and frequently expensive. The intravenous adenosine test has been used in the investigation of syncope and is cheap, safe and free of serious side effects. However, it is unclear what diagnosis the test unearths. There is some evidence that the test readily identifies bradycardia pacing indications.

In this study we plan to perform the adenosine test and implant a pacemaker should the test be positive. In half of the patients we will turn the pacemaker "on" and in the other half the pacemaker "off". The groups will swap over after six months. During this time we will assess the number of syncopal episodes. Also, in those who have a negative adenosine test we will implant a loop recorder to try to discover the cause of syncope.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: January 26, 2017
• Est. primary completion date: January 26, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Episode of syncope

• Patient has provided written informed consent for participation in the study prior to any study specific procedures

• Male or female

• Age > 40 years

• No cause of syncope clearly identified on clinical examination, lying and standing blood pressure measurements and standard 12 lead ECG.

Exclusion Criteria:

• Asthma or chronic obstructive pulmonary disease

• Severe coronary disease (myocardial infarction within 3 months, known coronary stenosis >70%, NYHA heart failure or angina symptoms Class III or IV)

• Known severe cerebrovascular disease or known significant internal carotid artery stenosis (>70%)

• Prolonged corrected QT interval

• Unablated accessory pathway

• Pregnancy or lactation

• Use of dipyridamole or any rate-limiting medication that cannot be safely discontinued

• Hypertrophic cardiomyopathy

• Cardiac transplantation

• Concurrent participation in another investigational study or trial

• Inability to give informed consent; carer/proxy assent will be allowed in this study

• Cause of syncope established from initial clinical history and examination, lying and standing blood pressure and ECG

Related Conditions & MeSH terms

• Syncope

Intervention

Device:
• Pacemaker implantation (Medtronic)
DDD+/-R pacing
• Pacemaker implantation (Medtronic)
ODO pacing
• Implantable Loop Recorder (Medtronic)
Loop recorder implantation

Locations

Country	Name	City	State
United Kingdom	Feeeman Hospital	Newcastle upon Tyne	Tyne And Wear
United Kingdom	Royal Victoria Infirmary	Newcastle upon Tyne	Tyne And Wear

Sponsors (1)

Lead Sponsor	Collaborator
Newcastle-upon-Tyne Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Syncope Burden	Syncope Burden as measured by number of syncopal episodes and recorded by weekly postal patient diaries with telephone reminders to ensure adequate return	12 months
Secondary	Time to first syncope	Time to first syncope	12 months
Secondary	Number of patients with recurrent syncope	Number of patients with >1 episodes of syncope	12 months
Secondary	Quality of life	Quality of life as measured via the condition-specific instrument the Impact of Syncope on Quality of Life questionnaire with general health-related quality of life measured via the WHOQoL-Brief and WHOQoL-Old instruments	12 months
Secondary	Health economic analysis	Costs and benefits of the intervention to health and social services. (i) Use of EQ-5D questionnaire to establish the cost per Quality Adjusted Life Year (QALY) (ii) The analysis will include the patients described above as well as a historical comparator group of consecutive patients derived from the database held by the Falls and Syncope Service who have not undergone adenosine testing. This group is particularly important to establish the utility of adenosine testing in the diagnosis of unexplained syncope.	12 months
Secondary	ECG diagnosis on ILR following syncopal episode in adenosine negative group	ECG diagnosis on ILR following syncopal episode in intravenous adenosine test negative group	12 months